JP2015222271A - 自己免疫疾患および萎縮性胃炎と関連する胃癌を診断するための方法および製品 - Google Patents
自己免疫疾患および萎縮性胃炎と関連する胃癌を診断するための方法および製品 Download PDFInfo
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Abstract
Description
本発明によるバイオマーカーは、主に、請求項8に記載のものを特徴とし、バイオマーカーの組合せは、主に、請求項9に記載のものを特徴とする。
(2)胃体部、幽門洞または両方に萎縮性胃炎がないと、胃癌のリスクは非常に低い。しかし、組織学的に観察可能な萎縮性胃炎を伴わないH.ピロリ感染が、胃癌および消化性潰瘍疾患を伴う場合がある。
(3)胃体部萎縮のある消化性潰瘍疾患はない(酸がなければ、潰瘍はない)。幽門洞萎縮がないと、消化性潰瘍疾患のリスクは非常に低い。
(4)低いガストリン−17(1,0pmol/l未満)を伴う正常(30−160μg/l)または高いペプシノーゲンIおよび/またはペプシノーゲンIとペプシノーゲンIIの比は、高い酸(HCl)の産出および胃食道逆流症(GERD)の合併症のリスクを示し得る。
(5)H.ピロリに関連する萎縮性胃炎の発生率を監視するとき、患者は、適切な時間に、標的化された安全な処置を受けることができる。かくして、薬物療法の必要性および薬物療法の費用および有害作用を低減できる。患者が消化性潰瘍疾患(胃潰瘍または十二指腸潰瘍)と診断されたことがある場合、H.ピロリ感染を処置しなければならない(6)。それは、患者が萎縮性胃炎を有する場合にも処置すべきである。患者および医師は、他の理由でも、例えば、患者の近親血縁者が胃癌と診断されたことがある場合にも、根絶処置に同意し得る。
(6)報道発表:2005年ノーベル生理学または医学賞、2005年10月3日、Barry Marshall および J. Robin Warren に共同で、彼らの「細菌ヘリコバクター・ピロリおよび胃炎および消化性潰瘍疾患におけるその役割」の発見に対して:−「ヘリコバクター・ピロリを健康な保菌者からも根絶するための抗生物質の無差別使用は、これらの重要な薬物に対する菌耐性の過酷な問題を導くであろう。従って、ヘリコバクター・ピロリに対する処置は、実証された胃潰瘍または十二指腸潰瘍の疾患のない患者においては限定的に使用されるべきである。」http://nobelprize.org/medicine/laureates/2005/press.html
(7)食物由来のカルシウムの適切な吸収は、萎縮性胃炎および長期のPPI治療において損なわれる正常な酸分泌を必要とする。その後、カルシウムは腸で正常に吸収されず、対象は、骨粗鬆症および股関節骨折のリスクにある。萎縮性胃炎および胃部分切除などの低酸症状態は、鉄欠乏性貧血の原因であると昔から知られている。
(8)処置2ヶ月後の10−15μg/l未満のペプシノーゲンIIレベルは、H.ピロリの根絶が成功したことを示す。高いレベルのペプシノーゲンII(10μg/lを超える)は、非ステロイド性抗炎症剤(例えば、アスピリン)または強いアルコールの使用に起因する活発なH.ピロリ胃炎または炎症を示す。Dig. Liver Dis. 2005 Jul; 37(7):501-8. Epub 2005 Apr 18.
胃体部に限定される萎縮性胃炎は、自己免疫性甲状腺炎並びに他の自己免疫過程と関連すると思われる。逆に、自己免疫性甲状腺炎を有する患者は、胃体部の萎縮性胃炎に冒されていると思われ、次いで、胃の新生物のリスクにあると思われる。61人のグレーブス病または橋本病の患者群において胃の粘膜の状態を GastroPanel(登録商標)で調査することを目的とする研究は、患者の約20パーセントが胃体部の萎縮性胃炎を示唆する血清学的なパターンを示すことを立証した。患者の18%に萎縮があり、25%に胃炎があり、57%は正常であった。萎縮を有する患者において:PGI<25μg/L、G−17>15pmol/L。胃炎を有する患者:PGII>10μg/L、IgG−Hp>42U/L。正常な患者:25<PGI>100μg/L、PGII<10μg/L、2.5<G−17>7.5pmol/L、IgG−Hp<44U/L。一般的な集団と比較すると、非常に高い割合が胃体の萎縮性胃炎を有した。生検を用いる上部GI内視鏡検査は、低いPGIレベルを有する患者の90%において、萎縮性胃炎の診断を確認した。これらの結果は、自己免疫性甲状腺炎を有する全患者での GastroPanel(登録商標)による検診の動機となる。
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Claims (9)
- 自己免疫疾患を示す症状および/またはバイオマーカーを有するヒトを検査する方法であって、
−該ヒトから生物学的サンプルを入手すること;
−1)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17およびヘリコバクター・ピロリ抗体、2)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17、3)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ヘリコバクター・ピロリ抗体、4)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、および、5)ペプシノーゲンIを含むバイオマーカーの群から選択される少なくとも1つのバイオマーカーを、該生物学的サンプルから定量的に測定し、得られる値をカットオフ値または基準範囲と比較すること、
を含む、方法。 - 該サンプル中のペプシノーゲンI濃度が下限に近いか、または、基準範囲またはカットオフ値を下回り、かつ、PGI/PGII比が下限に近いか、または、基準範囲またはカットオフ値を下回り、かつ、ガストリン−17濃度が上限に近いか、または、基準範囲を上回り、これらの値が萎縮性胃炎を示すものである、請求項1に記載の方法。
- ペプシノーゲンI値の基準範囲が30−160μg/lであり、ペプシノーゲンIIの基準範囲が3−20μg/lであり、PGI/PGII比が3または3未満であり、ガストリン−17S(刺激時)値の基準範囲が5−30pmol/lであり、ガストリン−17B(絶食時)の基準範囲が2−10pmol/lであり、HPABの基準範囲が0−30EIUである、請求項1または請求項2に記載の方法。
- 典型的なバイオマーカーのカットオフ値が、ペプシノーゲンI30μg/l、PGI/PGII比3、ガストリン−17S(刺激時)値5pmol/l、ガストリン−17B(絶食時)2pmol/lおよびHPAB30EIUを含む群から選択される、請求項1ないし請求項3のいずれかに記載の方法。
- 萎縮性胃炎を示す症状および/またはバイオマーカーを有するヒトを検査する方法であって、そのヒトを1つまたは複数の自己免疫疾患を示す症状および/またはバイオマーカーの存在について検査することを含む、方法。
- 生物学的サンプルが、血液、血清または血漿サンプルである、請求項1ないし請求項5のいずれかに記載の方法。
- 自己免疫疾患が、例えば、急性散在性脳脊髄炎、アジソン病、強直性脊椎炎、抗リン脂質抗体症候群、1型糖尿病、グッドパスチャー症候群、グレーブス病、ギラン・バレー症候群、橋本病、特発性血小板減少性紫斑病、エリテマトーデス、多発性硬化症、重症筋無力症、天疱瘡、関節リウマチ、シェーグレン症候群および側頭動脈炎を含む完全に自己免疫的原因の疾患、および、例えば、再生不良性貧血、自己免疫性肝炎、自己免疫性卵巣炎、小児脂肪便症、クローン病、妊娠性類天疱瘡、川崎病、眼球クローヌス・ミオクローヌス運動失調、視神経炎、オルド甲状腺炎、悪性貧血、原発性胆汁性肝硬変、ライター症候群、高安動脈炎、温式自己免疫性溶血性貧血およびウェゲナー肉芽腫症などの完全または部分的に自己免疫的原因の疾患を含む群から選択される、請求項1ないし請求項6のいずれかに記載の方法。
- 自己免疫疾患を示す症状および/またはバイオマーカーを有するヒトを、萎縮性胃炎の存在について検査するための;かつ/または、
萎縮性胃炎を示す症状および/またはバイオマーカーを有するヒトを、1つまたは複数の自己免疫疾患の存在について検査するための、
1)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17およびヘリコバクター・ピロリ抗体、2)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17、3)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ヘリコバクター・ピロリ抗体、4)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、および、5)ペプシノーゲンIを含むバイオマーカーの群から選択される、バイオマーカー。 - −1つまたは複数の自己免疫疾患の1つまたは複数のバイオマーカー、および、
−1)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17およびヘリコバクター・ピロリ抗体、2)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ガストリン−17、3)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、ヘリコバクター・ピロリ抗体、4)ペプシノーゲンI、ペプシノーゲンII、ペプシノーゲンI/II比、および、5)ペプシノーゲンIを含むバイオマーカーの群から選択される、1つまたは複数のバイオマーカー
を含む、生物学的サンプルを研究するためのバイオマーカーの組合せ。
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